EVOLYSSE® FORM and EVOLYSSE® SMOOTH
FDA premarket approval P240022/S001 · decided 2025-09-03
Approval details
- PMA number
- P240022
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- EVOLYSSE® FORM and EVOLYSSE® SMOOTH
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Symatese
- Date received
- 2025-04-30
- Decision date
- 2025-09-03
- Days to decision
- 126 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Chaponost
- Statement
- approval of the protocol for the post-approval study (PAS).
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